Regulatory Affairs Lead
Location: Burlington, ON, Canada

Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Specialist, Regulatory Affairs in our Regulatory Affairs function supporting the Spine division in Canada, you’ll play a key individual contributor role in preparing and coordinating regulatory submissions, ensuring compliance with local and regional requirements, and supporting the successful registration and maintenance of medical devices across the Canadian market.

What You’ll Do:

• Coordinate and prepare document packages for regulatory submissions for new and mature products to ensure alignment with Canadian and regional registration requirements
• Compile all materials required for submissions, license renewals, and annual registrations
• Recommend changes to labeling, manufacturing, marketing materials, and clinical protocols to achieve and maintain regulatory compliance
• Support internal audits and inspections by preparing documentation and responding to regulatory inquiries
• Monitor and improve tracking and control systems for regulatory submissions and compliance activities
• Stay current with evolving regulatory procedures, guidelines, and changes in Canadian medical device regulations
• Work cross-functionally with R&D, Quality, Clinical, and Marketing teams to gather necessary documentation and ensure timely submissions
• Perform detailed reviews and evaluative judgements on regulatory documentation to maintain high standards of accuracy and compliance

What You Bring:

• Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent combination of education and experience)
• 2+ years of experience in regulatory affairs, preferably in the medical device industry
• Solid understanding of Canadian medical device regulations (Health Canada) and familiarity with international standards (e.g., ISO 13485, MDR)
• Strong attention to detail with excellent organizational and document management skills
• Ability to work independently with minimal supervision and apply professional judgement
• Effective communication and collaboration skills to work with cross-functional teams
• Proficiency in compiling technical documentation and preparing submission packages
• Proactive approach to staying updated on regulatory changes and improving processes

Why VB Spine?
We believe in growing talent from within. At VB Spine, join a high-performing team, benefit from peer and executive mentorship, and contribute directly to bringing innovative spinal technologies to the Canadian market through strong regulatory compliance and submissions excellence.

Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, regulatory expertise, and local market conditions in Burlington, Ontario.

Benefits include:

• Comprehensive health, dental, and vision insurance
• Retirement savings plan with company match
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities
• Opportunity to grow within a fast-paced, dynamic company